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In vitro diagnostic medical devices
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IVD instruments
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General purpose IVD instruments
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Various general purpose IVD instruments
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Various general purpose IVD instruments - IVD medical device software
Various general purpose IVD instruments - IVD medical device software
W02079092
92 devices
Halia
Dedalus Italia SpA
·
,
Italy
Class A
CE/IVDR
Cosmas
MAK-SYSTEM Group Ltd.
·
,
United Kingdom
Class A
CE/IVDR
eTraceLine
MAK-SYSTEM Group Ltd.
·
,
United Kingdom
Class A
CE/IVDR
BenchLab CNV Software
Agilent Technologies Singapore (International) Pte Ltd
·
,
Singapore
Class A
CE/IVDR
GUDID
on market
Ikaros
MetaSystems Hard & Software GmbH
·
,
Germany
Class A
FDA 510(k)
K940240
Active
Cleared 24 Feb 1995
CE/IVDR
Metafer
MetaSystems Hard & Software GmbH
·
,
Germany
Class A
CE/IVDR
GUDID
on market
Agilent CytoDx Software
Agilent Technologies, Inc.
·
,
United States
Class C
CE/IVDR
ATMOSphere Urine
Dedalus Italia SpA
·
,
Italy
Class A
CE/IVDR
My+
Mylab Oy
·
,
Finland
IVD General
CE/IVDD
Concerto Ivdw
Dedalus Italia SpA
·
,
Italy
Class A
CE/IVDR
GeneFoxCub
Lacar MDX Technologies
·
,
Belgium
Class A
CE/IVDR
Analysis Software for Human 6 Gene Methylation and Alpha-Fetoprotein Combinator…
Genetron (Wuxi) Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Prometeo
Dedalus Italia SpA
·
,
Italy
Class A
CE/IVDR
My+ verikeskus
Mylab Oy
·
,
Finland
IVD General
CE/IVDD
Pathoxweb
Tesi Elettronica e Sistemi Informativi S.p.A.
·
,
Italy
Class A
CE/IVDR
AISight Dx
PathAI, Inc.
·
,
United States
Class A
FDA 510(k)
K243391
Active
Cleared 26 Jun 2025
CE/IVDR
Chromosome Analysis Suite Dx Software (ChAS Dx)
Affymetrix, Inc.
·
,
United States
Class C
CE/IVDR
GUDID
on market
ATMOSphere
Dedalus Italia SpA
·
,
Italy
Class A
CE/IVDR
Weblab
Tesi Elettronica e Sistemi Informativi S.p.A.
·
,
Italy
Class A
CE/IVDR
ATMOSphere Hematology
Dedalus Italia SpA
·
,
Italy
Class A
CE/IVDR
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